The Effect of rTMS Over the SMA on Gait Performance in Parkinson's Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-06

Study Completion Date

2027-04-30

Brief Summary

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This study aims to investigate the effects of high-frequency and low-frequency repetitive transcranial magnetic stimulation (rTMS) over the supplementary motor area (SMA) on gait performance, especially gait initiation, in individuals with Parkinson's disease (PD). Furthermore, the investigators will explore the impact of rTMS over the SMA on walking speed, functional mobility, and limits of stability in PD. It is hypothesized that rTMS over the SMA will improve gait performance in PD.

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Detailed Description

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The goal of this clinical trial is to investigate the effects of high-frequency and low-frequency rTMS over the SMA on gait performance, especially gait initiation, in individuals with PD. The primary outcome will be anticipatory postural adjustments (APAs) during gait initiation. The secondary outcome will include walking speed, the timed up-and-go test (TUG), and limits of stability.

The hypotheses are:

1. Both 25 Hz and 1 Hz rTMS will have a significant effect on gait performance, especially the gait initiation phase, as assessed by APAs in PD, compared with sham stimulation.
2. 25 Hz and 1 Hz rTMS will have a different effect on gait initiation in PD.

This study will be a three-arm, randomized, double-blind, placebo-controlled study examining the effect of 25 Hz or 1 Hz SMA-TMS compared with that observed after sham TMS. A total of 81 individuals with PD will be recruited and allocated into three different groups: 1 Hz TMS group, 25 Hz TMS group, and sham TMS group. Participants in each group will receive 10 TMS sessions over 2 weeks. Assessors will conduct evaluations at baseline, post-intervention, and 4-week post-intervention. The primary outcome will be APAs during gait initiation. The secondary outcome will include walking speed, TUG , and limits of stability.

Conditions

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PARKINSON DISEASE (Disorder)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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25 Hz repetitive transcranial magnetic stimulation group

High-frequency repetitive transcranial magnetic stimulation (25 Hz), intended to increase cortical excitability and provide facilitatory neuromodulation.

Group Type EXPERIMENTAL

Transcranial Magnetic Stimulation

Intervention Type DEVICE

The repetitive transcranial magnetic stimulation (rTMS) at different frequencies will deliver 10 sessions over 2 weeks. The participants will receive different stimulation protocols to the supplementary motor area while seated using a double-cone coil connected to a transcranial magnetic stimulator.

1 Hz repetitive transcranial magnetic stimulation group

Low-frequency repetitive transcranial magnetic stimulation (1 Hz), intended to decrease cortical excitability and provide inhibitory neuromodulation.

Group Type EXPERIMENTAL

Transcranial Magnetic Stimulation

Intervention Type DEVICE

The repetitive transcranial magnetic stimulation (rTMS) at different frequencies will deliver 10 sessions over 2 weeks. The participants will receive different stimulation protocols to the supplementary motor area while seated using a double-cone coil connected to a transcranial magnetic stimulator.

Sham stimulation group

The stimulation coil is positioned identically to active TMS and emits similar auditory and scalp sensations, but delivers no significant magnetic pulse to the brain, mimicking the active intervention experience without neuromodulatory effects.

Group Type PLACEBO_COMPARATOR

Transcranial Magnetic Stimulation Sham

Intervention Type DEVICE

The sham transcranial magnetic stimulation (TMS) will deliver 10 sessions over 2 weeks. The participants will receive the sham stimulation protocol to the supplementary motor area while seated using a double-cone coil connected to a transcranial magnetic stimulator.

Interventions

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Transcranial Magnetic Stimulation

The repetitive transcranial magnetic stimulation (rTMS) at different frequencies will deliver 10 sessions over 2 weeks. The participants will receive different stimulation protocols to the supplementary motor area while seated using a double-cone coil connected to a transcranial magnetic stimulator.

Intervention Type DEVICE

Transcranial Magnetic Stimulation Sham

The sham transcranial magnetic stimulation (TMS) will deliver 10 sessions over 2 weeks. The participants will receive the sham stimulation protocol to the supplementary motor area while seated using a double-cone coil connected to a transcranial magnetic stimulator.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. diagnosed with PD according to thecriteria set by Movement Disorder Committee,
2. with Hoehn and Yahr stages II-III, which are recognized as representing mild to moderate disease severity,
3. have self-reported difficulty in gait initiation, assessed by item 5 of the freezing of gait questionnaire (FOGQ),
4. have used a dopaminergic medication dose in the last month,
5. a minimum score of 23 of 30 points on the Montreal Cognitive Assessment (MoCA).

Exclusion Criteria

1. patients with unstable medical conditions,
2. unable to provide informed consent,
3. other neurological conditions including stroke,
4. contraindications for TMS,
5. experienced deep brain stimulation treatment,
6. no recordable motor evoked potentials (MEPs) with TMS.

Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No